Highly sophisticated chemical, biochemical or molecular biology based analyses, such as nucleic acid testing, NAT, in particular all modifications of polymerase chain reaction (PCR), become more and more attractive in medicine and health care as well as in nearly all fields of industry, including agriculture, biotechnology, chemical and environmental businesses. There is a great demand for analytical methods capable of satisfying the increasing requirements concerning, for instance, therapeutic outcome or planning and controlling of industrial manufacturing processes and costs.
Most of the state-of-the-art analytical systems are very complex, require handling of unstable reagents, expensive laboratory equipment and as well as highly trained personnel to conduct and interpret the testing. The analysis is therefore usually neither time-nor cost-effective as it involves sending a specimen to a specialised laboratory with considerable delay in obtaining results. For this reason, in-field and point-of-care testing (POCT) have become particularly desirable as they significantly shorten sampling-to-result time. In clinical diagnostic, some asymptomatic patients are likely to become impatient with the testing process and fail to attend the follow up appointment, thus should be offered proper treatment or reassurance during a single visit. There is also a prompt need for rapid, easy-to-perform tests for other in-field applications, e.g., forensic testing (“scene-of-crime”, “point-of-arrest”), food testing (GMO detection, food fraud), defence (bio-thread detection) and many more.
Lab-processed nucleic acid testing (NAT) has to date generally had much greater sensitivity than rapid POC tests, being usually based on pathogen immunodetection. Most of the NAT-based platforms and technologies currently under development do not provide an integrated solution for sample preparation, analysis and data evaluation. An example of a successful platform is described in WO 2005/106040 A2. Said device, however, requires manual loading of reagents which can be inconvenient for the user and error-prone. The data evaluation also requires operator intervention. It is therefore inappropriate for in-field testing. Further the complex lab-in-a-box design of the device, which consists of several large injection moulded parts and further several mounting parts such as filters, screws, and nuts, etc., results in high costs for the disposable device.